US20100160927A1 - Device for Preparing Tissue for Anastomosis - Google Patents
Device for Preparing Tissue for Anastomosis Download PDFInfo
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- US20100160927A1 US20100160927A1 US11/989,963 US98996306A US2010160927A1 US 20100160927 A1 US20100160927 A1 US 20100160927A1 US 98996306 A US98996306 A US 98996306A US 2010160927 A1 US2010160927 A1 US 2010160927A1
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- Prior art keywords
- tongue
- inelastic
- grip head
- graft
- pliant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1121—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis adapted for performing tissue or graft eversion
Definitions
- Devices and methods for everting tubular objects inside out are known.
- the material of the object is pierced by hooks that hold the material and enable everting of the material.
- the material and the quality of the final outcome may be damaged as a result of the several holes pierced in it.
- an end of a fabric tube is clamped between grips and pulled out to evert the material.
- tissue in the human body is everted using piercing prongs in a process which may cause damage to the tissue.
- U.S. Pat. No. 2,156,339 relates to a mechanism for reversing material in tubular form and, more specifically, to attaching means for use in connection therewith.
- U.S. Pat. No. 2,626,090 relates to a device for turning or reversing elongated tubular fabric articles such as belts, or the like.
- U.S. Pat. No. 3,945,542 discloses a device and method for manually everting a cloth or fabric tube where all manipulations may be visually monitored.
- U.S. Pat. No. 4,281,781 discloses a method of everting a knitted sleeve-like portion of wearing apparel, or the like.
- 2003/0032968 discloses a device and method for securing the urethra to the bladder in surgery by means of one or more everting prongs, which risks the intactness of the urethra and bladder. Some of these devices and methods are complicated and difficult for use and are not suitable for quick, easy and clean actions as required, for example, in operating rooms. Some of these devices and methods are not safe enough because damage may be caused to the everted materials.
- U.S. Patent Application Publication No. 2003/0130671 discloses a method for coupling a first vessel and a second vessel in an anastomosis.
- U.S. Patent Application Publication No. 2003/0135227 discloses an anastomosis device for use in coupling an end of a graft vessel to a side of a target vessel.
- U.S. Pat. No. 6,740,101 discloses anastomosis systems which include fittings and compression mechanisms for affecting end-end or end-side couplings of biological or synthetic bypass grafts to vessel locations.
- the known devices and methods are, as described above, based on the simultaneous everting of all the perimeter of an expandable tube end. These devices and methods require especially high elasticity of the material. In each of these methods and devices the everting becomes more difficult and unreliable as the diameter of the tube gets smaller.
- U.S. Patent Application Publication No. 2005/0038502 discloses docking heads to be mounted on a graft so as to establish-a vascular device that is coupled to a blood vessel with aneurysm, and dedicated delivery devices as well as methods of coupling.
- the vascular device comprises a graft having docking head at the proximal portion and another docking head at its distal portion, or two docking heads if the graft is bifurcated.
- the docking heads comprises a hollow truncated cone having a passage adapted to correspond to the outer diameter of the graft and is provided with a plurality of outwardly pointing and inclined barbs.
- the vascular device is coupled to the blood vessel on both sides of the aneurysm while the docking heads act as guiding, anchoring and sealing means in a suture-less and rapid manner.
- the vascular device is modular and can be prepared according to the condition of the aneurysm and the dimensions of the blood vessels during operation.
- Some embodiments of the present invention may include a device and/or method to enable easy and quick preparation of a graft and a fastener such as, for example, the docking heads described in U.S. 2005/0038502, for coupling to a vessel.
- Preparation of a graft and a fastener by gradually everting an edge of the graft over the fastener provides minimum stretching of the elastic graft, so that no damage to the graft may be caused and no extreme requirements on the elasticity of the graft are needed.
- Embodiments of the present invention may not require or cause piercing of the graft and therefore avoid possible damage to the graft.
- the easiness and quickness of the preparation of a fastener and graft according to embodiments of the present invention are especially important when used in operating rooms.
- the preparation according to embodiments of the present invention remains easy, quick and safe when the diameter of the graft gets smaller.
- a device for preparation of a graft and a fastener for coupling to a vessel may include a tubular body with a gripping head at a distal end to grip a tubular elastic object and a tubular inelastic object, wherein the elastic object may be threadable through the inelastic object, wherein an edge of the elastic object may emerge out of the inelastic object and wherein the external diameter of the head may be modifiable.
- the head of a device according to embodiment of the present invention may include, for example, at least three segments arranged around the axis of the head, wherein the segments can be brought closer or pushed away from each other to modify the external diameter of the head.
- a device may further include a pliant tongue which may be rotatable around the tubular body, wherein radial position of the tongue may be controllable, wherein the tongue may be axially slidable towards the grip head or away from the grip head.
- a device may further include a collet mandrel which may be insertable to the tubular body, wherein insertion of the collet mandrel into the tubular body may push the segments away from each other thus enlarging the external diameter of the head.
- a device may further include a springy cam which may be rotatable around the tubular body to limit at least one of lateral movement and radial movement of the tongue.
- the springy cam may position the tongue in a prescribed radial position.
- the springy cam may further include a first shoulder to limit insertion of the inelastic object on the head.
- the springy cam may further include a second shoulder to indicate proper insertion of the elastic object to enable everting of the edge on the inelastic object.
- the springy cam may further include a regulator to control radial position of the tongue.
- a device may further include a conical section, wherein the tongue may be slidable on the conical section.
- the conical section may include a shoulder to limit insertion of the inelastic object on the head.
- a method for preparation of a graft and a fastener for coupling to a vessel may include the step of threading a tubular elastic object through a tubular inelastic object, wherein an edge of the elastic object may emerge out of the inelastic object.
- a method according to an embodiment of the present invention may further include the steps of inserting the inelastic object together with the threaded elastic object on a grip head a part of the edge being pushed by, for example, the distal edge of a pliant tongue, which is in contact with the tongue, folding the part of the edge over the inelastic object, for example by further sliding the tongue over the inelastic object or sliding the edge over the tongue, and rotating the tongue around the inelastic object to gradually evert the edge over the inelastic object.
- a method according to an embodiment of the present invention may further include the step of modifying the external diameter of the grip head to reach firm griping of the inelastic object and the threaded elastic object.
- a method according to an embodiment of the present invention may further include the step of sliding the tongue under the edge of the elastic object.
- a method according to an embodiment of the present invention may further include the step of regulating the radial position of the tongue.
- FIG. 1 is a schematic isometric illustration of an everting device according to one embodiment the present invention
- FIG. 2 is a schematic isometric illustration of an everting device according to another embodiment the present invention.
- FIG. 3 is a schematic isometric illustration of an everting devite according to yet another embodiment the present invention.
- FIG. 4 is a schematic isometric illustration of an everting device according to yet another embodiment the present invention.
- FIG. 5 is a schematic cross section illustration of fastener and graft which may be everted on the fastener
- FIGS. 6A and 6B are partial schematic cross section illustrations of two conditions of a collet mandrel according to one embodiment of the invention.
- FIG. 7 is a detailed schematic isometric illustration of a springy cam according to one embodiment of the invention.
- FIGS. 8A to 8E are partial schematic cross section illustrations of an everting device according to one embodiment of the invention.
- FIGS. 9A and 9B are partial schematic illustrations of an everting device according to one embodiment of the invention.
- FIGS. 10A to 10C are partial schematic cross-sectional illustrations of everting devices according to embodiments of the invention.
- FIG. 11 is a flowchart describing a method according to one embodiment of the invention.
- the device and method according to embodiments of the present invention may enable gradual everting of an edge of a tubular elastic graft over a fastener, for example in order to prepare the graft and the fastener for coupling, e.g., in an easy and or quick manner. This may be especially important, for example, when used in operating rooms.
- the device and method according to embodiments of the present invention may reduce, e.g., minimize stretching of the elastic graft, so that substantially no damage to the graft may be caused, and/or no substantially extreme requirements on the elasticity of the graft may be needed, e.g. even when the diameter of the graft decreases.
- FIG. 1 is a schematic illustration of an everting device 11 according to an embodiment of the invention.
- Everting device 11 may include everter 27 , which may include a pliant tongue 29 .
- Everter 27 may rotate around cylindrical member 22 .
- Everter 27 may further slide axially on cylindrical member 22 .
- Everting device 11 may also include a grip head 23 .
- Grip head 23 may include an assembly having several segments 71 arranged around an axis of head 23 . Segments 71 may be brought closer or pushed away from each other to modify an external diameter of grip head 23 . The external diameter of grip head 23 may be modified when radial pressure is activated on grip head 23 .
- FIG. 1 shows three segments 71 , but the number of segments 71 may vary.
- More segments 71 will provide more freedom in modifying the outer diameter of grip head 23 , and may allow narrower slits between segments 71 . Narrower slits may prevent obstructions to the movement of pliant tongue 29 when it rotates around grip head 23 .
- Everting device 11 may also include a conical section 51 .
- Conical section 51 may function, for example, as a limiter to axial movement of a fastener (not shown in FIG. 1 ), as described below.
- Conical section 51 may facilitate sliding of pliant tongue 29 under a tubular member (not shown in FIG. 1 ) laid on grip head 23 and extending over conical section 51 , as described below.
- Everting device 11 may further include a flexibility section 24 which may provide flexibility to everting device 11 and may facilitate modifying of the external diameter of everting device 11 and grip head 23 .
- the slits between segnients 71 may extend through conical section 51 and flexibility section 24 , e.g., to allow further freedom in modifying the external diameter of grip head 23 .
- Everting device 11 may also include a collet mandrel 25 . Insertion of collet mandrel 25 into cylindrical member 22 may expand the diameter of flexibility section 24 and grip head 23 as described below. Insertion of collet mandrel 25 into cylindrical member 22 may be performed by, for example, mechanical force, hydraulic force, pneumatic force or a combination thereof.
- Collet mandrel 25 may include a knob 34 to facilitate rotation and thereby easy insertion and elicitation of collet mandrel 25 into cylindrical member 22 , by, for example, a worm (not shown).
- FIG. 2 is a schematic illustration of an everting device 10 according to another embodiment of the invention.
- everting device 10 may have the same functionality as everting device 11 (shown in FIGS. 1 , 8 A- 8 E and 9 A- 9 C).
- Everting device 10 may include a grooved section 45 between flexibility section 24 and grip bead 23 , the slits extending through grooved section 45 .
- Grooved section 45 may be used, for example, to hold means controlling the movement of pliant tongue 29 , as described in detail below.
- FIG. 3 is a schematic illustration of everting device 10 according to yet another embodiment of the invention.
- Springy cam 60 may be inserted on everting device 10 .
- Springy cam 60 may limit lateral and/or radial movement of pliant tongue 29 .
- Springy cam 60 may also position pliant tongue 29 in a desired radial position.
- Springy cam 60 may be rotatably supported on grooved section 45 .
- FIG. 4 is a schematic illustration of everting device 10 according to yet another embodiment of the invention.
- Springy cam 60 may further include a regulator 68 to limit radial movement outwardly of pliant tongue 29 , thus to control radial position of pliant tongue 29 , to enable proper folding and everting of a tubular member as described below.
- FIG. 5 is a schematic cross section illustration of a fastener 12 and a graft 13 which may be everted on fastener 12 using the device and method according to embodiments of the present invention.
- Fastener 12 may have a conical portion 12 a and a cylindrical portion 12 b. Inner diameters of cylindrical portion 12 b and of conical portion 12 a may coincide.
- Graft 13 may be inserted through conical portion 12 a and cylindrical portion 12 b, :e.g. such that some portion of graft 13 may emerge out of cylindrical portion 12 b, so as to be foldable over cylindrical portion 12 b.
- Conical portion 12 a may be provided with a plurality of inclined barbs; as shown in FIGS. 9A and 9 B.
- fastener 12 may be anchored to a blood vessel without sutures and/or in a quick manner.
- Fastener 12 may be formed of, for example, polymers, metals, special types of glass and other biocompatible materials.
- Graft 13 may be, for example, an artificial vascular graft or a natural graft made of a biological tissue.
- FIGS. 6A and 6B are partial schematic cross section illustrations of two conditions of collet mandrel 25 in everting device 10 , according to one embodiment of the invention.
- Collet mandrel 25 may have a conical end 31 .
- Collet mandrel 25 may be inserted into a cavity 21 .
- conical end 31 may be pushed between internal supports 96 of segments 71 ( FIG. 4 ), thus pushing internal supports 96 away from each other and expanding the external diameter of grip head 23 .
- collet mandrel 25 When the diameter of grip head 23 has expanded to reach firm gripping of fastener 12 and graft 13 , insertion of collet mandrel 25 may be stopped and the axial movement of collet mandrel 25 may be locked, e.g. due to the mechanical arrangement of the worm of collet mandrel 25 or any other suitable locking arrangement (not shown).
- the portion of graft 13 that emerges out of cylindrical portion 12 b may then be stretched out, and pliant tongue 29 may be positioned in a required radial position to enable pliant tongue 29 to slide on cylindrical portion 12 b, as seen in FIG. 6A .
- Springy cam 60 may be rotatably supported on grooved section 45 and may support pliant tongue 29 , as described above.
- Pliant tongue 29 may slide axially towards fastener 12 .
- a part of graft 13 which is in contact with pliant tongue 29 may he pushed up by pliant tongue 29 and may be folded over cylindrical portion 12 b, as seen in FIG. 6B .
- Pliant tongue 29 may then be rotated to encircle cylindrical portion 12 b.
- the portion of graft 13 that emerges out of cylindrical portion 12 b may be gradually everted over cylindrical portion 12 b.
- pliant tongue 29 may slide away from fastener 12 .
- Collet mandrel 25 may then be pulled away from internal supports 96 , e.g.
- springy cam 50 may have the same functionality as springy cam 60 (shown in FIGS. 3 , 4 , 6 A- 6 B and 10 A- 10 C).
- Springy cam 50 may include a first shoulder 62 .
- First shoulder 62 may include a socket 63 to laterally support pliant tongue 29 ( FIGS. 6A and 6B ).
- First shoulder 62 may position pliant tongue 29 in a prescribed radial position.
- First shoulder 62 may provide barrier to limit insertion of fastener 12 ( FIGS. 6A and 6B ) onto grip head 23 ( FIGS. 6A and 6B ).
- springy cam 50 may include a second shoulder 61 .
- Second shoulder 61 may include a passage 64 to support pliant tongue 29 radially and/or axially. Passage 66 may further include a regulator 68 to limit radial position of pliant tongue 29 to enable proper folding and everting of an edge of graft 13 over cylindrical portion 12 b. Second shoulder 61 may indicate proper length of the portion of graft 13 ( FIGS. 6A and. 6 B) inserted onto grip head 23 ( FIGS. 6A and 6B ). The size of springy cam 50 may be chosen to match a diameter of a specific fastener 12 . Springy cam 50 may include an arch 67 . Arch 67 may be elastic.
- An internal diameter of arch 67 may be slightly smaller than an outer diameter of grooved section 45 (not shown).
- Springy cam 50 may be installed on grooved section 45 by pushing arch 67 , e.g. forcefully, onto grooved section 45 .
- a portion of the perimeter of grooved section 45 may be unoccupied by arch 67 , thus preventing over stretching of graft 13 .
- FIGS. 8A-8E are partial schematic cross section illustration of everting device 11 illustrating different stages of everting graft 13 onto fastener 12 according to an embodiment of the invention.
- FIGS. 9A and 9B are additional partial schematic illustrations of these stages.
- Graft 13 may be inserted on everting device 11 so that the end of graft 13 may rest upon a shoulder of conical section 51 .
- Fastener 12 may be inserted on graft 13 until the outer edge of cylindrical portion 12 b meets the shoulder of conical section 51 .
- FIGS. 8A-8E are partial schematic cross section illustration of everting device 11 illustrating different stages of everting graft 13 onto fastener 12 according to an embodiment of the invention.
- FIGS. 9A and 9B are additional partial schematic illustrations of these stages.
- Graft 13 may be inserted on everting device 11 so that the end of graft 13 may rest upon a shoulder of conical section 51 .
- Fastener 12 may be inserted on graft 13 until the outer edge of cylindrical portion 12
- graft 13 may be inserted on everting device 11 until the end of graft 13 meets second shoulder 61 and fastener 12 may be inserted until the edge of cylindrical portion 12 b meets first shoulder 62 .
- the diameter of grip head 23 may then be adjusted to firmly hold fastener 12 and graft 13 together, for example by inserting collet mandrel 25 into cylindrical member 22 , as described above with reference to FIGS. 6A and 6B .
- pliant tongue 29 may slide on conical section 51 under the portion of graft 13 that emerges out of cylindrical portion 12 b ( FIG. 8A ).
- the part of graft 13 that is in contact with pliant tongue 29 may be pushed up and inversely by pliant tongue 29 ( FIG. 8B ) and may be folded over the edge of fastener 12 by further sliding pliant tongue 29 axially over cylindrical portion 12 b and turning pliant tongue 29 in a rotary motion ( FIG. 8C ). Pliant tongue 29 may then be further rotated to encircle cylindrical portion 12 b. By rotation of pliant tongue 29 , the portion of graft 13 that emerges out of cylindrical portion 12 b may be gradually folded and everted over the edge of fastener 12 ( FIGS. 8D and 8E ). When pliant tongue 29 completes a substantially full circle around cylindrical portion 12 b, the portion of graft 13 that emerges out of fastener 12 may be fully everted ( FIG. 8E ).
- FIGS. 10A to 10C are partial schematic cross-sectional illustrations of everting devices 101 , 102 , 103 according to some embodiments of the invention.
- everting devices 101 , 102 , 103 may have the same functionality as everting device 10 (shown in FIGS. 2-4 and 6 A- 6 B) and/or everting device 11 (shown in FIGS. 1 , 8 A- 8 E and 9 A- 9 C).
- Devices according to embodiments of the present invention may vary in shape and/or size to fit to, different diameters or diameter ranges of graft 13 and/or fastener 12 .
- the shape and size of head 23 may vary in different embodiments of devices of the present invention to match different shapes and/or sizes of graft 13 and/or fastener 12 .
- the shape and/or size of pliant tongue 29 may vary in different embodiments of devices of the present invention to match different shapes and/or sizes of graft 13 and/or fastener 12 .
- FIGS. 10A to 10C show, for example, different shapes and different relative sizes of head 23 , pliant tongue 29 , collet mandrel 25 , conical end 31 and springy cam 60 , so as to fit different diameters and/or ranges of diameters of graft 13 and/or fastener 12 , e.g. while maintaining the functionalities of gripping of fastener 12 with graft 13 , everting of the end of graft 13 and releasing fastener 12 with everted graft 13 substantially, as described above.
- the method may include threading graft 13 through fastener 12 .
- the method may include, inserting graft 13 and fastener 12 on grip head 23 .
- the method may include modifying the external diameter of grip head 23 thereby reaching firm griping of fastener 12 and graft 13 .
- the method may include regulating the radial position of pliant tongue 29 , for example by regulator 68 .
- the method may include sliding pliant tongue 29 under the portion of graft 13 that emerges out of cylindrical portion 12 b.
- the method may include pushing, for example by pliant tongue 29 , the part of graft 13 that is in contact with pliant tongue 29 .
- the method may include The method of FIG. 11 may further include folding the part of graft 13 that is in contact with pliant tongue 29 over cylindrical portion 12 b, for example by further sliding pliant tongue 29 over cylindrical portion 12 b.
- the method may include rotating pliant tongue 29 around cylindrical portion 12 b thereby gradually everting the portion of graft 13 that emerges out of cylindrical portion 12 b.
Abstract
Description
- Devices and methods for everting tubular objects inside out are known. In some examples, the material of the object is pierced by hooks that hold the material and enable everting of the material. In these examples the material and the quality of the final outcome may be damaged as a result of the several holes pierced in it. In other examples, an end of a fabric tube is clamped between grips and pulled out to evert the material. In further other examples, tissue in the human body is everted using piercing prongs in a process which may cause damage to the tissue. Some of the known devices and methods are complicated and difficult for use and are not suitable for quick, easy and clean actions as required, for example, in operating rooms. Some of the known devices and methods are not safe and unreliable. Some of the known devices and methods do not enable full everting. U.S. Pat. No. 2,156,339 relates to a mechanism for reversing material in tubular form and, more specifically, to attaching means for use in connection therewith. U.S. Pat. No. 2,626,090 relates to a device for turning or reversing elongated tubular fabric articles such as belts, or the like. U.S. Pat. No. 3,945,542 discloses a device and method for manually everting a cloth or fabric tube where all manipulations may be visually monitored. U.S. Pat. No. 4,281,781 discloses a method of everting a knitted sleeve-like portion of wearing apparel, or the like. U.S. Patent Application Publication No. 2003/0032968 discloses a device and method for securing the urethra to the bladder in surgery by means of one or more everting prongs, which risks the intactness of the urethra and bladder. Some of these devices and methods are complicated and difficult for use and are not suitable for quick, easy and clean actions as required, for example, in operating rooms. Some of these devices and methods are not safe enough because damage may be caused to the everted materials.
- Devices and methods for coupling grafts to vessels are known. U.S. Patent Application Publication No. 2003/0130671 discloses a method for coupling a first vessel and a second vessel in an anastomosis. U.S. Patent Application Publication No. 2003/0135227 discloses an anastomosis device for use in coupling an end of a graft vessel to a side of a target vessel. U.S. Pat. No. 6,740,101 discloses anastomosis systems which include fittings and compression mechanisms for affecting end-end or end-side couplings of biological or synthetic bypass grafts to vessel locations. Some of these devices and methods are difficult to use and time consuming, especially for small graft diameters. Some of these devices and methods expose foreign material to the blood flow path within the vessels, which increases the risks of hemolysis and thrombosis.
- The known devices and methods are, as described above, based on the simultaneous everting of all the perimeter of an expandable tube end. These devices and methods require especially high elasticity of the material. In each of these methods and devices the everting becomes more difficult and unreliable as the diameter of the tube gets smaller.
- U.S. Patent Application Publication No. 2005/0038502 discloses docking heads to be mounted on a graft so as to establish-a vascular device that is coupled to a blood vessel with aneurysm, and dedicated delivery devices as well as methods of coupling. The vascular device comprises a graft having docking head at the proximal portion and another docking head at its distal portion, or two docking heads if the graft is bifurcated. The docking heads comprises a hollow truncated cone having a passage adapted to correspond to the outer diameter of the graft and is provided with a plurality of outwardly pointing and inclined barbs. The vascular device is coupled to the blood vessel on both sides of the aneurysm while the docking heads act as guiding, anchoring and sealing means in a suture-less and rapid manner. The vascular device is modular and can be prepared according to the condition of the aneurysm and the dimensions of the blood vessels during operation.
- Some embodiments of the present invention may include a device and/or method to enable easy and quick preparation of a graft and a fastener such as, for example, the docking heads described in U.S. 2005/0038502, for coupling to a vessel. Preparation of a graft and a fastener by gradually everting an edge of the graft over the fastener provides minimum stretching of the elastic graft, so that no damage to the graft may be caused and no extreme requirements on the elasticity of the graft are needed. Embodiments of the present invention may not require or cause piercing of the graft and therefore avoid possible damage to the graft. The easiness and quickness of the preparation of a fastener and graft according to embodiments of the present invention are especially important when used in operating rooms. The preparation according to embodiments of the present invention remains easy, quick and safe when the diameter of the graft gets smaller.
- According to an embodiment of the present invention, a device for preparation of a graft and a fastener for coupling to a vessel may include a tubular body with a gripping head at a distal end to grip a tubular elastic object and a tubular inelastic object, wherein the elastic object may be threadable through the inelastic object, wherein an edge of the elastic object may emerge out of the inelastic object and wherein the external diameter of the head may be modifiable. The head of a device according to embodiment of the present invention may include, for example, at least three segments arranged around the axis of the head, wherein the segments can be brought closer or pushed away from each other to modify the external diameter of the head. A device according to an embodiment of the present invention may further include a pliant tongue which may be rotatable around the tubular body, wherein radial position of the tongue may be controllable, wherein the tongue may be axially slidable towards the grip head or away from the grip head.
- A device according to an embodiment of the present invention may further include a collet mandrel which may be insertable to the tubular body, wherein insertion of the collet mandrel into the tubular body may push the segments away from each other thus enlarging the external diameter of the head.
- A device according to an embodiment of the present invention may further include a springy cam which may be rotatable around the tubular body to limit at least one of lateral movement and radial movement of the tongue. The springy cam may position the tongue in a prescribed radial position. The springy cam may further include a first shoulder to limit insertion of the inelastic object on the head. The springy cam may further include a second shoulder to indicate proper insertion of the elastic object to enable everting of the edge on the inelastic object. The springy cam may further include a regulator to control radial position of the tongue.
- A device according to an embodiment of the present invention may further include a conical section, wherein the tongue may be slidable on the conical section. The conical section may include a shoulder to limit insertion of the inelastic object on the head.
- According to an embodiment of the present invention, a method for preparation of a graft and a fastener for coupling to a vessel may include the step of threading a tubular elastic object through a tubular inelastic object, wherein an edge of the elastic object may emerge out of the inelastic object. A method according to an embodiment of the present invention may further include the steps of inserting the inelastic object together with the threaded elastic object on a grip head a part of the edge being pushed by, for example, the distal edge of a pliant tongue, which is in contact with the tongue, folding the part of the edge over the inelastic object, for example by further sliding the tongue over the inelastic object or sliding the edge over the tongue, and rotating the tongue around the inelastic object to gradually evert the edge over the inelastic object.
- A method according to an embodiment of the present invention may further include the step of modifying the external diameter of the grip head to reach firm griping of the inelastic object and the threaded elastic object.
- A method according to an embodiment of the present invention may further include the step of sliding the tongue under the edge of the elastic object.
- A method according to an embodiment of the present invention may further include the step of regulating the radial position of the tongue.
- The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:
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FIG. 1 is a schematic isometric illustration of an everting device according to one embodiment the present invention; -
FIG. 2 is a schematic isometric illustration of an everting device according to another embodiment the present invention; -
FIG. 3 is a schematic isometric illustration of an everting devite according to yet another embodiment the present invention; -
FIG. 4 is a schematic isometric illustration of an everting device according to yet another embodiment the present invention; -
FIG. 5 is a schematic cross section illustration of fastener and graft which may be everted on the fastener; -
FIGS. 6A and 6B are partial schematic cross section illustrations of two conditions of a collet mandrel according to one embodiment of the invention; -
FIG. 7 is a detailed schematic isometric illustration of a springy cam according to one embodiment of the invention; -
FIGS. 8A to 8E are partial schematic cross section illustrations of an everting device according to one embodiment of the invention; -
FIGS. 9A and 9B are partial schematic illustrations of an everting device according to one embodiment of the invention. -
FIGS. 10A to 10C are partial schematic cross-sectional illustrations of everting devices according to embodiments of the invention. -
FIG. 11 is a flowchart describing a method according to one embodiment of the invention. - It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.
- In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.
- The device and method according to embodiments of the present invention may enable gradual everting of an edge of a tubular elastic graft over a fastener, for example in order to prepare the graft and the fastener for coupling, e.g., in an easy and or quick manner. This may be especially important, for example, when used in operating rooms. The device and method according to embodiments of the present invention may reduce, e.g., minimize stretching of the elastic graft, so that substantially no damage to the graft may be caused, and/or no substantially extreme requirements on the elasticity of the graft may be needed, e.g. even when the diameter of the graft decreases.
- Reference is made to
FIG. 1 , which is a schematic illustration of aneverting device 11 according to an embodiment of the invention.Everting device 11 may includeeverter 27, which may include apliant tongue 29.Everter 27 may rotate aroundcylindrical member 22.Everter 27 may further slide axially oncylindrical member 22.Everting device 11 may also include agrip head 23.Grip head 23 may include an assembly havingseveral segments 71 arranged around an axis ofhead 23.Segments 71 may be brought closer or pushed away from each other to modify an external diameter ofgrip head 23. The external diameter ofgrip head 23 may be modified when radial pressure is activated ongrip head 23. For demonstration only,FIG. 1 shows threesegments 71, but the number ofsegments 71 may vary.More segments 71 will provide more freedom in modifying the outer diameter ofgrip head 23, and may allow narrower slits betweensegments 71. Narrower slits may prevent obstructions to the movement ofpliant tongue 29 when it rotates aroundgrip head 23.Everting device 11 may also include aconical section 51.Conical section 51 may function, for example, as a limiter to axial movement of a fastener (not shown inFIG. 1 ), as described below.Conical section 51 may facilitate sliding ofpliant tongue 29 under a tubular member (not shown inFIG. 1 ) laid ongrip head 23 and extending overconical section 51, as described below.Everting device 11 may further include aflexibility section 24 which may provide flexibility to evertingdevice 11 and may facilitate modifying of the external diameter of evertingdevice 11 andgrip head 23. The slits betweensegnients 71 may extend throughconical section 51 andflexibility section 24, e.g., to allow further freedom in modifying the external diameter ofgrip head 23.Everting device 11 may also include acollet mandrel 25. Insertion ofcollet mandrel 25 intocylindrical member 22 may expand the diameter offlexibility section 24 andgrip head 23 as described below. Insertion ofcollet mandrel 25 intocylindrical member 22 may be performed by, for example, mechanical force, hydraulic force, pneumatic force or a combination thereof.Collet mandrel 25 may include aknob 34 to facilitate rotation and thereby easy insertion and elicitation ofcollet mandrel 25 intocylindrical member 22, by, for example, a worm (not shown). - Reference is made to
FIG. 2 , which is a schematic illustration of aneverting device 10 according to another embodiment of the invention. Although the invention is not limited in this respect, evertingdevice 10 may have the same functionality as everting device 11 (shown inFIGS. 1 , 8A-8E and 9A-9C).Everting device 10 may include agrooved section 45 betweenflexibility section 24 andgrip bead 23, the slits extending through groovedsection 45.Grooved section 45 may be used, for example, to hold means controlling the movement ofpliant tongue 29, as described in detail below. - Reference is made to
FIG. 3 , which is a schematic illustration of evertingdevice 10 according to yet another embodiment of the invention.Springy cam 60 may be inserted on evertingdevice 10.Springy cam 60 may limit lateral and/or radial movement ofpliant tongue 29.Springy cam 60 may also positionpliant tongue 29 in a desired radial position.Springy cam 60 may be rotatably supported ongrooved section 45. - Reference is made to
FIG. 4 , which is a schematic illustration of evertingdevice 10 according to yet another embodiment of the invention.Springy cam 60 may further include aregulator 68 to limit radial movement outwardly ofpliant tongue 29, thus to control radial position ofpliant tongue 29, to enable proper folding and everting of a tubular member as described below. - Reference is made to
FIG. 5 , which is a schematic cross section illustration of afastener 12 and agraft 13 which may be everted onfastener 12 using the device and method according to embodiments of the present invention.Fastener 12 may have aconical portion 12 a and acylindrical portion 12 b. Inner diameters ofcylindrical portion 12 b and ofconical portion 12 a may coincide.Graft 13 may be inserted throughconical portion 12 a andcylindrical portion 12 b, :e.g. such that some portion ofgraft 13 may emerge out ofcylindrical portion 12 b, so as to be foldable overcylindrical portion 12 b.Conical portion 12 a may be provided with a plurality of inclined barbs; as shown inFIGS. 9A and 9B. Afterfastener 12 andgraft 13 are coupled using the device and method according to embodiments of the present invention, e.g., as described below,fastener 12 may be anchored to a blood vessel without sutures and/or in a quick manner.Fastener 12 may be formed of, for example, polymers, metals, special types of glass and other biocompatible materials.Graft 13 may be, for example, an artificial vascular graft or a natural graft made of a biological tissue. - Reference is made to
FIGS. 6A and 6B , which are partial schematic cross section illustrations of two conditions ofcollet mandrel 25 ineverting device 10, according to one embodiment of the invention.Collet mandrel 25 may have aconical end 31.Collet mandrel 25 may be inserted into acavity 21. When insertingcollet mandrel 25 intocavity 21,conical end 31 may be pushed betweeninternal supports 96 of segments 71 (FIG. 4 ), thus pushinginternal supports 96 away from each other and expanding the external diameter ofgrip head 23. When the diameter ofgrip head 23 has expanded to reach firm gripping offastener 12 andgraft 13, insertion ofcollet mandrel 25 may be stopped and the axial movement ofcollet mandrel 25 may be locked, e.g. due to the mechanical arrangement of the worm ofcollet mandrel 25 or any other suitable locking arrangement (not shown). The portion ofgraft 13 that emerges out ofcylindrical portion 12 b may then be stretched out, andpliant tongue 29 may be positioned in a required radial position to enablepliant tongue 29 to slide oncylindrical portion 12 b, as seen inFIG. 6A .Springy cam 60 may be rotatably supported ongrooved section 45 and may supportpliant tongue 29, as described above.Pliant tongue 29 may slide axially towardsfastener 12. A part ofgraft 13 which is in contact withpliant tongue 29 may he pushed up bypliant tongue 29 and may be folded overcylindrical portion 12 b, as seen inFIG. 6B .Pliant tongue 29 may then be rotated to encirclecylindrical portion 12 b. By rotation ofpliant tongue 29, the portion ofgraft 13 that emerges out ofcylindrical portion 12 b may be gradually everted overcylindrical portion 12 b. When the eversion is completed,pliant tongue 29 may slide away fromfastener 12.Collet mandrel 25 may then be pulled away frominternal supports 96, e.g. by turningknob 34 backwards, thus enabling the external diameter ofgrip head 23 to be reduced. When the external diameter ofgrip head 23 is reduced, the gripping offastener 12 andgraft 13 ongrip head 23 may be released, andfastener 12 together withgraft 13 may be removed fromgrip head 23. - Refernce is made to
FIG. 7 , which is a detailed schematic illustration ofspringy cam 50 according to one embodiment of the invention. Although the invention is not limited in this respect,springy cam 50 may have the same functionality as springy cam 60 (shown inFIGS. 3 , 4, 6A-6B and 10A-10C).Springy cam 50 may include afirst shoulder 62.First shoulder 62 may include asocket 63 to laterally support pliant tongue 29 (FIGS. 6A and 6B ).First shoulder 62 may positionpliant tongue 29 in a prescribed radial position.First shoulder 62 may provide barrier to limit insertion of fastener 12 (FIGS. 6A and 6B ) onto grip head 23 (FIGS. 6A and 6B ). According to some embodimentsspringy cam 50 may include asecond shoulder 61.Second shoulder 61 may include a passage 64 to supportpliant tongue 29 radially and/or axially.Passage 66 may further include aregulator 68 to limit radial position ofpliant tongue 29 to enable proper folding and everting of an edge ofgraft 13 overcylindrical portion 12 b.Second shoulder 61 may indicate proper length of the portion of graft 13 (FIGS. 6A and. 6B) inserted onto grip head 23 (FIGS. 6A and 6B ). The size ofspringy cam 50 may be chosen to match a diameter of aspecific fastener 12.Springy cam 50 may include an arch 67.Arch 67 may be elastic. An internal diameter ofarch 67 may be slightly smaller than an outer diameter of grooved section 45 (not shown).Springy cam 50 may be installed on groovedsection 45 by pushingarch 67, e.g. forcefully, onto groovedsection 45. A portion of the perimeter ofgrooved section 45 may be unoccupied by arch 67, thus preventing over stretching ofgraft 13. - Reference is made to
FIGS. 8A-8E , which are partial schematic cross section illustration of evertingdevice 11 illustrating different stages of evertinggraft 13 ontofastener 12 according to an embodiment of the invention.FIGS. 9A and 9B are additional partial schematic illustrations of these stages.Graft 13 may be inserted on evertingdevice 11 so that the end ofgraft 13 may rest upon a shoulder ofconical section 51.Fastener 12 may be inserted ongraft 13 until the outer edge ofcylindrical portion 12 b meets the shoulder ofconical section 51. In the embodiment illustrated inFIGS. 6A and 6B graft 13 may be inserted on evertingdevice 11 until the end ofgraft 13 meetssecond shoulder 61 andfastener 12 may be inserted until the edge ofcylindrical portion 12 b meetsfirst shoulder 62. The diameter ofgrip head 23 may then be adjusted to firmly holdfastener 12 andgraft 13 together, for example by insertingcollet mandrel 25 intocylindrical member 22, as described above with reference toFIGS. 6A and 6B . When insertingfastener 12 withgraft 13 ondevice 11,pliant tongue 29 may slide onconical section 51 under the portion ofgraft 13 that emerges out ofcylindrical portion 12 b (FIG. 8A ). The part ofgraft 13 that is in contact withpliant tongue 29 may be pushed up and inversely by pliant tongue 29 (FIG. 8B ) and may be folded over the edge offastener 12 by further slidingpliant tongue 29 axially overcylindrical portion 12 b and turningpliant tongue 29 in a rotary motion (FIG. 8C ).Pliant tongue 29 may then be further rotated to encirclecylindrical portion 12 b. By rotation ofpliant tongue 29, the portion ofgraft 13 that emerges out ofcylindrical portion 12 b may be gradually folded and everted over the edge of fastener 12 (FIGS. 8D and 8E ). Whenpliant tongue 29 completes a substantially full circle aroundcylindrical portion 12 b, the portion ofgraft 13 that emerges out offastener 12 may be fully everted (FIG. 8E ). - Reference is now made to
FIGS. 10A to 10C , which are partial schematic cross-sectional illustrations of evertingdevices devices FIGS. 2-4 and 6A-6B) and/or everting device 11 (shown inFIGS. 1 , 8A-8E and 9A-9C). Devices according to embodiments of the present invention may vary in shape and/or size to fit to, different diameters or diameter ranges ofgraft 13 and/orfastener 12. The shape and size ofhead 23 may vary in different embodiments of devices of the present invention to match different shapes and/or sizes ofgraft 13 and/orfastener 12. The shape and/or size ofpliant tongue 29 may vary in different embodiments of devices of the present invention to match different shapes and/or sizes ofgraft 13 and/orfastener 12.FIGS. 10A to 10C show, for example, different shapes and different relative sizes ofhead 23,pliant tongue 29,collet mandrel 25,conical end 31 andspringy cam 60, so as to fit different diameters and/or ranges of diameters ofgraft 13 and/orfastener 12, e.g. while maintaining the functionalities of gripping offastener 12 withgraft 13, everting of the end ofgraft 13 and releasingfastener 12 witheverted graft 13 substantially, as described above. - Reference is made to
FIG. 11 , whiCh is a flowchart describing a method for everting an edge ofgraft 13 over the edge offastener 12 according to one embodiment of the invention. As indicated inblock 110, the method may include threadinggraft 13 throughfastener 12. As indicated inblock 112, the method may include, insertinggraft 13 andfastener 12 ongrip head 23. As indicated inblock 114, the method may include modifying the external diameter ofgrip head 23 thereby reaching firm griping offastener 12 andgraft 13. As indicated inblock 116, the method may include regulating the radial position ofpliant tongue 29, for example byregulator 68. As indicated inblock 118, the method may include slidingpliant tongue 29 under the portion ofgraft 13 that emerges out ofcylindrical portion 12 b. As indicated inblock 120, the method may include pushing, for example bypliant tongue 29, the part ofgraft 13 that is in contact withpliant tongue 29. As indicated inblock 122, the method may include The method ofFIG. 11 may further include folding the part ofgraft 13 that is in contact withpliant tongue 29 overcylindrical portion 12 b, for example by further slidingpliant tongue 29 overcylindrical portion 12 b. As indicated inblock 124, the method may include rotatingpliant tongue 29 aroundcylindrical portion 12 b thereby gradually everting the portion ofgraft 13 that emerges out ofcylindrical portion 12 b. - While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.
Claims (19)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/IL2006/000923 WO2007066317A2 (en) | 2006-08-10 | 2006-08-10 | Device tor preparing tissue for anastomosis |
Publications (2)
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US20100160927A1 true US20100160927A1 (en) | 2010-06-24 |
US8323299B2 US8323299B2 (en) | 2012-12-04 |
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US11/989,963 Expired - Fee Related US8323299B2 (en) | 2006-08-10 | 2006-08-10 | Device for preparing tissue for anastomosis |
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US (1) | US8323299B2 (en) |
EP (1) | EP2049027A4 (en) |
WO (1) | WO2007066317A2 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104107078A (en) * | 2013-04-19 | 2014-10-22 | 瑞奇外科器械(中国)有限公司 | Anastomat and nail anvil component thereof |
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2006
- 2006-08-10 US US11/989,963 patent/US8323299B2/en not_active Expired - Fee Related
- 2006-08-10 EP EP06780385A patent/EP2049027A4/en not_active Withdrawn
- 2006-08-10 WO PCT/IL2006/000923 patent/WO2007066317A2/en active Application Filing
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US2156339A (en) * | 1937-10-01 | 1939-05-02 | Emil F Horn | Mechanism for reversing material |
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Also Published As
Publication number | Publication date |
---|---|
US8323299B2 (en) | 2012-12-04 |
WO2007066317A2 (en) | 2007-06-14 |
EP2049027A4 (en) | 2013-03-20 |
WO2007066317A9 (en) | 2008-08-07 |
WO2007066317A8 (en) | 2012-10-11 |
EP2049027A2 (en) | 2009-04-22 |
WO2007066317A3 (en) | 2007-11-01 |
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